Randstad Engineering Manager in Raynham, Massachusetts
Raynham, MA Salary:
US$ 41 - US$ 55 per hour Date Posted:
Thursday, October 13, 2016 Experience:
7 years Job Type:
A leader in pharmaceutical manufacturing is currently seeking a Staff External Manufacturing Engineer in the Raynham, MA area. This is a 1 year CONTRACT position. No per diem is provided.
Responsibilities for the Engineering Manager
Work with external suppliers to validating process changes related to devices, and/or replacement of obsolete materials or tooling. Initiating/leading/supporting cost improvement projects and business continuity initiatives.
Interface with External Manufacturers and External Operations groups and assist by providing technical support to insure External Manufacturers are properly evaluated/selected/qualified. Provide technical support to assist in establishing and maintaining GMP compliant processes.
Perform engineering studies and analyses on existing manufacturing processes to improve process reliability, product quality and cost. Using appropriate statistical techniques to develop validation protocols, complete process capability studies and process validation on both internal and supplier processes.
Actively participate in other team activities to help insure total team success; take an active role in learning for self and others to further company objectives; complete assignments involving a specific phase of an engineering project and / or line support activity.
Assist in determining objectives and planning schedules of specific task within a given project / activity; provide line support responsibilities for specific products. Coordinate technical and or business issues with internal and external customers (typical scope is at a business unit level)
Requirements for the Engineering Manager
A minimum of a Bachelors degree in engineering is required for this position and 7+ years experience in industry is required, preferably in the medical device field. Knowledge and practical experience with process development, process controls and process validation (e.g. control plans, pFMEAs, CTQ Cascade, etc.) is required.
Experience with packaging of sterile devices is highly desired. Experience working with global supply chain and non-US raw material and finished goods suppliers is highly desired. Prior experience participating in process efficiency improvement, technology transfer into base business, or cost reduction projects is highly desired.
Process Excellence training or certification is highly desired (Six Sigma Green or Black Belt). Knowledge of statistical tools such as DOE, or Hypothesis Testing Tools is a plus.
Job Number: 126059